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Dockets Management

Dockets Entered On December 19, 2006
Table of Contents
Docket # Title
1977N-0094L Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment ot the Tentative Final Monograph; Required Warnings and Other Labeling
1978N-0065 Skin Bleaching Drug Products
2002P-0317 Recall Aspartame as a Neurotoxic Drug
2003N-0056 Patient Examination & Surgeons' Gloves; Test Procedures
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
2005N-0403 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2006D-0383 Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
2006N-0062 Expanded Access to Investigational Drugs for Treatment Use
2006N-0292 Unique Device Identification
2006N-0414 Suicidality Data from Adult Antidepressant Trials
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2006P-0415 Petition Seeking Regulation of Cloned Animals
2006P-0506 Request that the FDA announce an Advance Notice of Proposed Rulemaking regarding the use of symbols on the principal display panel that would communicate to consumers the healthfulness of foods.
2006P-0523 Require ANDA applicant for generic of Eloxatin solution as reference drug perform clinical testing
1977N-0094L Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment ot the Tentative Final Monograph; Required Warnings and Other Labeling
NPR 1 FDA Vol #: 1
1978N-0065 Skin Bleaching Drug Products
EC 156 Ms. Christy Scott Vol #: 14
EC 157 Dr. Ellen Gendler Vol #: 14
EC 158 American Academy of Dermatology Vol #: 14
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 746 Calorie Control Council Vol #: 10
EMC 747 B. Martini Vol #: 10
2003N-0056 Patient Examination & Surgeons' Gloves; Test Procedures
NFR 1 FDA Vol #: 1
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EMC 1399 T. Fletcher Vol #: 12
EMC 1400 No Submitter Vol #: 12
EMC 1401 V. Eberle Vol #: 12
EMC 1402 A. Dunlap Vol #: 12
EMC 1403 No Submitter Vol #: 12
EMC 1404 T. McMullen Vol #: 12
2005N-0403 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
EREG 1 National Committee on Vital & Health Statistics Vol #: 3
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
EMC 4181 D. Landreth Vol #: 199
EMC 4182 S. Kimble Vol #: 199
EMC 4183 C. Vohl Vol #: 199
EMC 4184 J. Sackman Vol #: 199
EMC 4185 J. Mullin Vol #: 199
EMC 4186 G. Vieira Vol #: 199
2006D-0383 Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
C 280 Dr. Hartmann Vol #: 22
C 281 L. Dirtman Vol #: 22
C 282 A. Pugliese Vol #: 22
C 283 D. Hils Vol #: 22
C 284 C. Russell Vol #: 22
C 285 R. Culbertson Vol #: 22
EC 3605 Mr. Glenn Simon Vol #: 18
EC 3606 Mrs. Catherine Simon Vol #: 18
EC 3607 Mrs. Chris Burkart Vol #: 18
EC 3608 na Vol #: 18
EC 3609 Mrs. Claudia Chandler Vol #: 18
EC 3610 Mr. Joseph O'Kane Vol #: 18
EC 3611 Miss. Stephanie Howe Vol #: 18
EC 3612 holy family catholic church Vol #: 18
EC 3613 Mrs. Judy Ashby Vol #: 18
EC 3614 Roman Catholic Church Vol #: 18
EC 3615 Mrs. Donna Yinger Vol #: 18
EC 3616 Mr. Frank Cosentino Vol #: 18
EC 3617 Mr. Don Cazeaux Vol #: 18
EC 3618 Mr. Paul Beargie Vol #: 18
EC 3619 Ms. Julie Nichols Vol #: 18
EC 3620 Mrs. Susan Lloyd Vol #: 18
EC 3621 Drew University Vol #: 18
EC 3622 Mrs. Sandra Kruse Vol #: 18
EC 3623 Mr. Ed Brancheau Vol #: 18
EC 3624 Ms. Eileen Croce Vol #: 18
EC 3625 Mrs. Kathleen Arrnold Vol #: 18
EC 3626 Dr. John Zmirak Vol #: 18
EC 3627 Mr. Ted Schluenderfritz Vol #: 18
EC 3628 Dr. Michael Krafczyk Vol #: 18
EC 3629 Mr. Michael Willett Vol #: 18
EC 3630 Mr. Eugene Terefenko Vol #: 18
EC 3631 Mr. Roanld and Luann LMJ Bloom Vol #: 18
EC 3632 Dr. Michelle Weigand Vol #: 18
EC 3633 Mrs. Tricia O'Connor Vol #: 18
EC 3634 Mrs. Rose Wingfield Vol #: 18
EC 3635 Mrs. Jean McKearn Vol #: 18
EC 3636 St Joseph's Home for the Poor Vol #: 18
EC 3637 Ms. Tanya Tybur Vol #: 18
EC 3638 Mr. Rudolph Geter Vol #: 18
EC 3639 Mr. William Spearman Vol #: 18
EC 3640 Mr. Joseph O'Connor, III Vol #: 18
EC 3641 University of Dallas Vol #: 18
EC 3642 Mr. Thomas Keenan Vol #: 18
EC 3643 none Vol #: 18
EC 3644 Mrs. Marie Helms Vol #: 18
EC 3645 Mrs. Sally Hultgren Vol #: 18
EC 3646 Mr. Jacob Huether Vol #: 18
EC 3647 Mrs. Erika Huether Vol #: 18
EC 3648 Mrs. Carol Carlson, RN Vol #: 18
EC 3649 Ms. Amanda Steinke Vol #: 18
EC 3650 Mrs. Laraine Bennett Vol #: 18
EC 3651 Mrs. Karen Surmont Vol #: 18
EC 3652 Ms. Marcella Colbert Vol #: 18
EC 3653 Mr. Hans Schade Vol #: 18
EC 3654 Mr. Jonathan Gazave Vol #: 18
EC 3655 Mr. PAUL MEYER Vol #: 18
EC 3656 Mr. John Knutsen Vol #: 18
EC 3657 Mr. Pavel Tikhonov Vol #: 18
EC 3658 Holy Roman Catholic Vol #: 18
EC 3659 Mrs. Christine Lund-Molfese Vol #: 18
EC 3660 Mrs. Tenny Brannan Vol #: 18
EC 3661 Holy Roman Catholic Vol #: 18
EC 3662 Pro-life Vol #: 18
EC 3663 none Vol #: 18
EC 3664 Mrs. Jane Greenwood Vol #: 18
EC 3665 Mr. Joseph DiMaggio III Vol #: 18
EC 3666 Mrs. Jeanne Ostrich Vol #: 18
EC 3667 Dr. Joseph Szmerekovsky Vol #: 18
EC 3668 Mrs. regina athenas Vol #: 18
EC 3669 Mrs. cindy nicolosi Vol #: 18
EC 3670 N/A Vol #: 18
EC 3671 Knights of Columbus Vol #: 18
EC 3672 Miss. Marguerite Ozburn Vol #: 18
EC 3673 self Vol #: 18
EC 3674 Ms. Dana Williams Vol #: 18
EC 3675 Mrs. Rhonda Ortiz Vol #: 18
EC 3676 Mrs. Kelly Perrault Vol #: 18
EC 3677 Miss. Catherine Martin Vol #: 18
EC 3678 Mrs. Teresa Tyrrell Vol #: 18
EC 3679 Mrs. Joan Lund Vol #: 18
EC 3680 University of St. Francis Vol #: 18
EC 3681 Miss. Constance Nielsen Vol #: 18
EC 3682 Mr. Ramon Vales Vol #: 18
EC 3683 Mrs. Allison Theubet Vol #: 18
EC 3684 Mrs. Karen Bava Vol #: 18
EC 3685 Mrs. Brigitte Desimone Vol #: 18
EC 3686 Mr. Thomas Nosacek Vol #: 18
EC 3687 Mrs. Wanda Tansey, RN Vol #: 18
EC 3688 Mrs. Lissette Yellico Vol #: 18
EC 3689 University of Colorado- Boulder Vol #: 18
EC 3690 Mr. Elwin Falor Vol #: 18
EC 3691 Ms. Faith Chou Vol #: 18
EC 3692 Mrs. Susan Rosentel Vol #: 18
EC 3693 Mrs. grace hagerman Vol #: 18
EC 3694 Mr. David Lauryn Vol #: 18
EC 3695 NVMS Vol #: 18
EC 3696 Pro-Life wisconsin/Respect for Life Vol #: 18
EC 3697 Mr. Michael Wullaert Vol #: 18
EC 3698 Mrs. mg ronan Vol #: 18
EC 3699 Mr. David McDonough Vol #: 18
EC 3700 Mr. Anthony Kotecki Vol #: 18
EC 3701 Mrs. Judith Horn Vol #: 18
EC 3702 Dr. Gregory Dieter Vol #: 18
EC 3703 Mrs. Eileen Wegendt Vol #: 18
EC 3704 Mrs. Therese Given Vol #: 18
EC 3705 Mrs. Helen Lyons Vol #: 18
EC 3706 Mr. Joseph Schmeier Vol #: 18
EC 3707 Mr. Daniel Mortenson Vol #: 18
EC 3708 Mr. Gregory Smisek Vol #: 18
EC 3709 Mrs. Ana Haase-Elliott Vol #: 18
EC 3710 Miss. Helen Laverdure Vol #: 18
EC 3711 Mrs. rachel morson Vol #: 18
EC 3712 Mrs. Jack Fraker Vol #: 18
EC 3713 Mr. Wayne Howard Vol #: 18
EC 3714 Mr. Pat Kadian Vol #: 18
EC 3715 Mrs. Margaret Reif Vol #: 18
EC 3716 Medivas Vol #: 18
EC 3717 Mr. Tim O'Malley Vol #: 18
EC 3718 Mrs. Mary Ann Ormiston Vol #: 18
EC 3719 Mrs. Lorraine Carreira Vol #: 18
EC 3720 Mrs. Emily Cook Vol #: 18
EC 3721 Ms. Nora Sullivan Vol #: 18
EC 3722 Ms. Karen Clark Nagy Vol #: 18
EC 3723 Dr. David Johnson Vol #: 18
EC 3724 Mr. Paul Friederich Vol #: 18
EC 3725 Mrs. Kathryn Ricketts Vol #: 18
EC 3726 Mr. James Melnick Vol #: 18
EMC 5 J Schmelzer Vol #: 13
EMC 6 L Ball and family Vol #: 13
EMC 7 M McGee Vol #: 13
EMC 8 E Sedgwick Vol #: 13
EMC 9 Dr G Snider Vol #: 13
EMC 10 J Golian Vol #: 13
2006N-0062 Expanded Access to Investigational Drugs for Treatment Use
EREG 1 D. Kaylor Vol #: 1
2006N-0292 Unique Device Identification
EMC 2 B. Braun Medical, Inc. Vol #: 6
2006N-0414 Suicidality Data from Adult Antidepressant Trials
EMC 18 R. Cleghorn Vol #: 2
EMC 19 N. Fredricks Vol #: 2
2006P-0394 Revise the labeling requirements for eggs sold in the United States
EC 449 Ms. Lois Wye Vol #: 7
EC 450 Ms. Jennifer Demers Vol #: 7
EC 451 Mrs. Brenda Elizondo Vol #: 7
2006P-0415 Petition Seeking Regulation of Cloned Animals
EMC 11 C. Brueckner Vol #: 2
2006P-0506 Request that the FDA announce an Advance Notice of Proposed Rulemaking regarding the use of symbols on the principal display panel that would communicate to consumers the healthfulness of foods.
LET 1 FDA/DDM to Center for Science in the Public Interest Vol #: 1
2006P-0523 Require ANDA applicant for generic of Eloxatin solution as reference drug perform clinical testing
ACK 1 Sanofi-aventis US LLP Vol #: 1
CP 1 Sanofi-aventis US LLP Vol #: 1

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